Development and validation of limited sampling strategies for estimation of cyclosporine area under the concentration-time curve in hematopoietic stem cell transplant patients

Therapeutic Drug Monitoring

Volumn 33, Issue 6, 2011, Pages 673-680

  Hadjibabaie, Molouk ^a   Vazirian, Iman ^a   Iravani, Masoud ^b   Moosavi, Seyed Asadollah ^b   Alimoghaddam, Kamran ^b   Ghavamzadeh, Ardeshir ^b   Rezaee, Saeed ^c  

^a TEHRAN UNIVERSITY OF MEDICAL SCIENCES   (Iran)

^b TEHRAN UNIVERSITY OF MEDICAL SCIENCES   (Iran)

^c AHVAZ JUNDISHAPUR UNIVERSITY OF MEDICAL SCIENCES   (Iran)

Author keywords

AUC; Bone marrow transplantation; Cyclosporine; Limited sampling methods

Indexed keywords

BUSULFAN; CYCLOPHOSPHAMIDE; CYCLOSPORIN A; FLUDARABINE; METHOTREXATE; THYMOCYTE ANTIBODY;

ACUTE GRANULOCYTIC LEUKEMIA; ACUTE LYMPHOBLASTIC LEUKEMIA; ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; APLASTIC ANEMIA; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; BOOTSTRAPPING; CHRONIC MYELOID LEUKEMIA; CLINICAL ARTICLE; CONTROLLED STUDY; DOSE TIME EFFECT RELATION; DRUG MONITORING; FANCONI ANEMIA; FEMALE; GRAFT VERSUS HOST REACTION; HUMAN; MALE; MYELODYSPLASTIC SYNDROME; PREDICTION; PRIORITY JOURNAL; STEADY STATE; SYSTEMATIC ERROR; THALASSEMIA; VALIDATION PROCESS;

ADOLESCENT; ADULT; BONE MARROW TRANSPLANTATION; CYCLOSPORINE; DRUG MONITORING; FEMALE; GRAFT VS HOST DISEASE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; IRAN; LINEAR MODELS; MALE; MODELS, BIOLOGICAL; YOUNG ADULT;

EID: 84856110150     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0b013e318235a5df     Document Type: Article

References (45)

1. Duncan N, Craddock C. Optimizing the use of cyclosporin in allogeneic stem cell transplantation. Bone Marrow Transplant. 2006;38:169-174. (Pubitemid 44102943)
2. Holler E. Risk assessment in haematopoietic stem cell transplantation: GvHD prevention and treatment. Best Pract Res Clin Haematol. 2007;20:281-294. (Pubitemid 46585971)
3. Barkholt L, Remberger M, Bodegard H, et al. Cyclosporine A (CsA) 2-h concentrations vary between patients without correlation to graft-versushost disease after allogeneic haematopoietic stem cell transplantation. Bone Marrow Transplant. 2007;40:683-689. (Pubitemid 47456483)
4. Jorga A, Holt DW, Johnston A. Therapeutic drug monitoring of cyclosporine. Transplant Proc. 2004;36:396S-403S. (Pubitemid 38373898)
5. Willemze AJ, Cremers SC, Schoemaker RC, et al. Ciclosporin kinetics in children after stem cell transplantation. Br J Clin Pharmacol. 2008;66:539-545.
6. Jaiswal J, Gupta SK, Dash SC, et al. Neoral monitoring by limited sampling area under the concentration time curve in stable Indian renal transplant recipients. Transplant Proc. 2003;35:1298-1299. (Pubitemid 36765514)
7. Citterio F. Evolution of the therapeutic drug monitoring of cyclosporine. Transplant Proc. 2004;36:420S-425S. (Pubitemid 38373902)
8. Wang CH, Ko WJ, Chou NK, et al. A limited sampling strategy for the estimation of 12-hour cyclosporine neoral area under the curve in Chinese cardiac transplant recipients. Transplant Proc. 2004;36:2390-2392. (Pubitemid 39550854)
9. Johnston A, Sketris I, Marsden JT, et al. A limited sampling strategy for the measurement of cyclosporine AUC. Transplant Proc. 1990;22:1345-1346. (Pubitemid 20205533)
10. Dumont RJ, Ensom MH. Methods for clinical monitoring of cyclosporin in transplant patients. Clin Pharmacokinet. 2000;38:427-447. (Pubitemid 30265262)
11. David OJ, Johnston A. Limited sampling strategies for estimating cyclosporin area under the concentration-time curve: review of current algorithms. Ther Drug Monit. 2001;23:100-114. (Pubitemid 32240136)
12. Dotti G, Gaspari F, Caruso R, et al. Pharmacokinetic study of the new cyclosporine-a formulation (Neoral) in adult allogeneic bone marrow transplant recipients. Haematologica. 2001;86:311-315. (Pubitemid 32291070)
13. Pawinski T, Hale M, Korecka M, et al. Limited sampling strategy for the estimation of mycophenolic acid area under the curve in adult renal transplant patients treated with concomitant tacrolimus. Clin Chem. 2002;48:1497-1504. (Pubitemid 34925784)
14. Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm. 1981;9:503-512.
15. Melter M, Rodeck B, Kardorff R, et al. Pharmacokinetics of cyclosporine in pediatric long-term liver transplant recipients converted from Sandimmun to Neoral. Transpl Int. 1997;10:419-425. (Pubitemid 27494170)
16. Primmett DR, Levine M, Kovarik JM, et al. Cyclosporine monitoring in patients with renal transplants: two-or three-point methods that estimate area under the curve are superior to trough levels in predicting drug exposure. Ther Drug Monit. 1998;20:276-283. (Pubitemid 28248847)
17. Keown P, Landsberg D, Halloran P, et al. A randomized, prospective multicenter pharmacoepidemiologic study of cyclosporine microemulsion in stable renal graft recipients. Report of the Canadian Neoral Renal Transplantation Study Group. Transplantation. 1996;62:1744-1752.
18. Foradori AC, Mezzano S, Martinez L, et al. Clinically specific sparse sampling method for the evaluation of cyclosporine A (Cy A) exposure in stable kidney transplantation. Ther Drug Monit. 1999;21:435.
19. Gaspari F, Perico N, Signorini O, et al. Abbreviated kinetic profiles in area-under-the-curve monitoring of cyclosporine therapy. Kidney Int. 1998;54:2146-2150. (Pubitemid 28533644)
20. Marsh CL. Abbreviated pharmacokinetic profiles in area-under-the-curve monitoring of cyclosporine therapy in de novo renal transplant patients treated with Sandimmune or Neoral. Neoral Study Group. Ther Drug Monit. 1999;21:27-34. (Pubitemid 29077451)
21. Araújo Pereira ME, Alves do Carmo J, Forjaz Lacerda JM, et al. Therapeutic monitoring of cyclosporine-A in bone marrow transplantation: past and present [abstract]. Ther Drug Monit. 1997;19:559.
22. Meier-Kriesche HU, Bonilla-Felix MA, Ferris ME, et al. A limited sampling strategy for the estimation of Neoral AUCs in pediatric patients. Pediatr Nephrol. 1999;13:742-747.
23. Kahan BD, Welsh M, Rutzky LP. Challenges in cyclosporine therapy: the role of therapeutic monitoring by area under the curve monitoring. Ther Drug Monit. 1995;17:621-624.
24. Mahalati K, Belitsky P, Sketris I, et al. Neoral monitoring by simplified sparse sampling area under the concentration-time curve: its relationship to acute rejection and cyclosporine nephrotoxicity early after kidney transplantation. Transplantation. 1999;68:55-62. (Pubitemid 29352830)
25. Willemze AJ, Press RR, Lankester AC, et al. CsA exposure is associated with acute GVHD and relapse in children after SCT. Bone Marrow Transplant. 2010;45:1056-1061.
26. Furukawa T, Kurasaki-Ida T, Masuko M, et al. Pharmacokinetic and pharmacodynamic analysis of cyclosporine A (CsA) to find the best single time point for the monitoring and adjusting of CsA dose using twice-daily 3-h intravenous infusions in allogeneic hematopoietic stem cell transplantation. Int J Hematol. 2010;92:144-151.
27. Hendriks MP, Blijlevens NM, Schattenberg AV, et al. Cyclosporine short infusion and C2 monitoring in haematopoietic stem cell transplant recipients. Bone Marrow Transplant. 2006;38:521-525. (Pubitemid 44445358)
28. Gaspari F, Anedda MF, Signorini O, et al. Prediction of cyclosporine area under the curve using a three-point sampling strategy after Neoral administration. J Am Soc Nephrol. 1997;8:647-652.
29. Molpeceres J, Chacon M, Guzman M, et al. A polycaprolactone nanoparticle formulation of cyclosporin-A improves the prediction of area under the curve using a limited sampling strategy. Int J Pharm. 1999;187:101-113. (Pubitemid 29435977)
30. Pawinski T, Kunicki PK, Sobieszczanska-Malek M, et al. A limited sampling strategy for estimating mycophenolic acid area under the curve in adult heart transplant patients treated with concomitant cyclosporine. J Clin Pharm Ther. 2009;34:89-101.
31. Dumont RJ, Partovi N, Levy RD, et al. A limited sampling strategy for cyclosporine area under the curve monitoring in lung transplant recipients. J Heart Lung Transplant. 2001;20:897-900. (Pubitemid 32737524)
32. Proost JH. Validation of limited sampling models (LSM) for estimating AUC in therapeutic drug monitoring-is a separate validation group required? Int J Clin Pharmacol Ther. 2007;45:402-409. (Pubitemid 47045483)
33. Meier-Kriesche HU, Alloway R, Gaber AO, et al. A limited sampling strategy for the estimation of 12-hour SangCya and neoral AUCs in renal transplant recipients. J Clin Pharmacol. 1999;39:166-171. (Pubitemid 29068162)
34. Meier-Kriesche HU, Kaplan B, Brannan P, et al. A limited sampling strategy for the estimation of eight-hour neoral areas under the curve in renal transplantation. Ther Drug Monit. 1998;20:401-407. (Pubitemid 28359990)
35. Filler G, Mai I, Filler S, et al. Abbreviated cyclosporine AUCs on Neoral-the search continues! Pediatr Nephrol. 1999;13:98-102. (Pubitemid 29206230)
36. D'Agostino D, Gimenez M, Yamaguchi B, et al. Conversion and pharmacokinetic studies of a microemulsion formulation of cyclosporine in pediatric liver transplant patients. Transplantation. 1996;62:1068-1071. (Pubitemid 26376653)
37. Cantarovich M, Barkun J, Besner JG, et al. Cyclosporine peak levels provide a better correlation with the area-under-the-curve than trough levels in liver transplant patients treated with Neoral. Transplant Proc. 1998;30:1462-1463. (Pubitemid 28309645)
38. Wang CH, Chou NK, Wu FL, et al. Therapeutic drug monitoring of cyclosporine Neoral in de novo Chinese cardiac transplant recipients treated with an everolimus-cyclosporine immunosuppressive regimen. Transplant Proc. 2006;38:2132-2134.
39. de Mattos AM, Munar MY, Olyaei AJ, et al. Validation of models for predicting area-under-the curve in renal transplant patients receiving Neoral. Transplantation. 1999;67:S149.
40. Sindhi R, Shah J, Foley L, et al. Abbreviating area under the curves further: a practical approach to monitoring extended pharmacokinetics with Neoral. Transplant Proc. 1998;30:1197-1198. (Pubitemid 28309537)
41. Serafinowicz A, Gaciong Z, Baczkowska T, et al. Limited sampling strategy to estimate exposure to cyclosporine A in renal allograft recipients treated with Sandimmune-Neoral. Transplant Proc. 1996;28:3138-3139. (Pubitemid 26415425)
42. Serafinowicz A, Gaciong Z, Majchrzak J, et al. Abbreviated kinetic profiles to estimate exposure to CyA in renal allograft recipients treated with Sandimmun-Neoral. Transplant Proc. 1997;29:277-279. (Pubitemid 27123406)
43. Johnston A, David OJ, Cooney GF. Pharmacokinetic validation of neoral absorption profiling. Transplant Proc. 2000;32:53S-56S. (Pubitemid 30256284)
44. Belitsky P, Levy GA, Johnston A. Neoral absorption profiling: an evolution in effectiveness. Transplant Proc. 2000;32:45S-52S. (Pubitemid 30256283)
45. Mahalati K, Lawen J, Kiberd B, et al. Is 3-hour cyclosporine blood level superior to trough level in early post-renal transplantation period? J Urol. 2000;163:37-41.